NCT06592703 Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis
| NCT ID | NCT06592703 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rennes University Hospital |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-03-06 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, we propose, for the first time, to test the safety and the potential efficacy of repeated allogenic Adipose tissue-derived Mesenchymal Stromal Cells IT injections in Primary Progressive Multiple Sclerosis patients.
Eligibility Criteria
Inclusion Criteria: * Patient with Primary Progressive MS according to the criteria of Mc Donald 2017 (Thompson et al Lancet neurol, 2017) * Age between 18 and 55 years * EDSS score: 3 to 6 at inclusion * Documented evidence of disability progression independent of relapse activity at any point in time over the 2 years prior to the screening visit * Positive CSF with oligoclonal bands * For women of childbearing potential (WOCBP), effective contraception as per the CFTG recommendations (version 1.1) * Having signed a free, informed and written consent * Affiliated to social security scheme Exclusion Criteria: * Inflammatory activity during the past year (relapses or new T2 MRI lesions) * Disease Modifying Drugs during the past year * Treatment with high dose corticosteroids during the 30 days preceding the inclusion * Contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (\<50 G/L), anticoagulant or fibrinolytic treatment * Participation in another therapeutic trial in the last 6 months * Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to express their consent
Contact & Investigator
Laure MICHEL, Pr
PRINCIPAL INVESTIGATOR
Rennes University Hospital
Frequently Asked Questions
Who can join the NCT06592703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06592703 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06592703 currently recruiting?
Yes, NCT06592703 is actively recruiting participants. Contact the research team at laure.michel@chu-rennes.fr for enrollment information.
Where is the NCT06592703 trial being conducted?
This trial is being conducted at Créteil, France, Rennes, France.
Who is sponsoring the NCT06592703 clinical trial?
NCT06592703 is sponsored by Rennes University Hospital. The principal investigator is Laure MICHEL, Pr at Rennes University Hospital. The trial plans to enroll 10 participants.
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